RP 3-15

Collection and Transfer of Samples and Information by the Biosample Center at the Radiation Effects Research Foundation

Summary

Multifactorial diseases are the result of complex interactions among lifestyle, environment, individual sensitivity, genetic components, and other factors. In recent years, researchers of these diseases comprehensively perform clinical and epidemiological analysis to identify contributing lifestyle and environmental factors in conjunction with basic research using biological samples. This comprehensive approach not only elucidates causes of specific diseases but leads to the establishment of methods for their early detection and prevention. To be useful for research, biological samples must be of adequate quality, volume and number and must satisfy ethical criteria based on the informed consent of sample donors. Additionally, high-quality clinical, epidemiological, and pathological information must be available for samples. Thus, to satisfy these conditions, the importance of infrastructural development for “biobanks” that support large-scale research using human samples is increasing.

The Atomic Bomb Casualty Commission (ABCC) and Radiation Effects Research Foundation (RERF) have long retained biological samples provided by A-bomb survivors and their children, such as blood, urine, pathological specimens, and teeth. But, until this time, individual researchers and research departments were entrusted to select sample storage methods and manage sample information. Realizing the need to indefinitely preserve our valuable biological sample collection in good condition and promote research that uses these samples, the integrated management of samples, and the establishment of sample information databases, RERF established the Biosample Center (hereinafter: “the Center”) in April 2013.

Samples and related information kept at individual research departments will be transferred to the Center when it begins operating, and samples collected after the start of operations will be handled and stored in the Center according to written procedures. Sample information will be integrally managed in RERF databases. Quality control of stored samples will be conducted periodically in accordance with a “Quality Control Manual” to be created for the Center. The Center will collaborate with the Committee on Biological Samples to formulate detailed regulations governing the use of RERF biological samples. Researchers and other employees involved in the activities of the Center will be required to observe the “Radiation Effects Research Foundation Regulations for Protection of Personal Information” as well as all applicable laws, regulations, and guidelines, including Japanese government ethical guidelines pertaining to biomedical research involving human subjects and human genome and genetic analysis. Informed consent information will be stored in the databases and associated with the samples. Every sample provided will be appropriately anonymized.

Thus, the Center aims to integrally manage RERF’s biological samples and sample information to ensure that they can be stored and used properly to further elucidate the role of radiation in diseases and biological and molecular changes in A-bomb survivors and their children.

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